Since the 80s, ephedra had become popular for weight loss and enhancing sports performance and was used in many nutritional supplements marketed for weight loss and sports performance in the United States up until these supplements were banned in 2006 by the Food and Drug Administration (FDA). Here is the recent history of ephedra regulation:
A study published in the medical journal Annals of Internal Medicine in 2003 found that products containing ephedra accounted for 64% of all adverse reactions to herbs reported in the United States in 2001, even though ephedra sales made up less than 1% of herbal supplement sales in the United States.
On February 17, 2003, 23-year-old Baltimore Orioles pitcher Steve Bechler died of heatstroke in Fort Lauderdale, Florida, after collapsing the day before during a workout at Fort Lauderdale Stadium. The local medical examiner reportedly said that the ephedra Bechler had been taking to lose weight may have contributed to his death.
Bechler's highly publicized death is believed to have been a key factor in the FDA's announcement on December 30, 2003 that it was planning to ban dietary supplements with ephedra because of the health risks.
The FDA also issued a consumer alert, advising consumers to stop buying and using ephedra. Although ephedra dropped sharply, 14% of people using non-prescription weight loss supplements in the United States continued to take ephedra or products containing ephedrine.
The judge ruled that the FDA had come to their decision by doing a risk-benefit analysis, considered inappropriate for supplements under a 1994 law (called the Dietary Supplement Health and Education Act (DSHEA)). Also the DSHEA required dose-specific findings to justify a ban and that the FDA had insufficient evidence to conclude that products with 10 mg or less a day of ephedrine alkaloids posed a risk. As a result, products with 10 mg or less of ephedra alkaloids were allowed back on the market.
The court ruled that the 133,000 page administrative record, which included 19,000 adverse events reports, compiled by the FDA was sufficent to support the inital finding that supplements containing ephedrine alkaloids at any dose posed an unreasonable risk of illness and injury and that the risk-benefit analysis was required.
The FDA stated that no dose of dietary supplements containing ephedrine alkaloids was safe and that the sale of these products in the United States was illegal and subject to enforcement action.
Up until this ruling, many herbal supplement companies marketed low-dose ephedra products containing 10 mg or less of ephedra alkaloids.
2007: Nutraceutical Corporation filed a petition for rehearing in front of the tenth circuit of the US Court of Appeals, however the United States Supreme Court declined to hear the petition.
